CataractPhase 4NCT02089698
Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification
A Phase 4 study testing Mini-flared and Reversed tip in people with Cataract, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
Trial summary
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Mini-flared and Reversed tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.
Who cannot join
- Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Oftalmologico de Brasília
Brasília, Federal District, 70000
About this study
Official title: Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.
Read the detailed description
In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).
The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.
- Conditions
- Cataract
- Being tested
- Mini-flared, Reversed tip
- Keywords
- Kelman tip, Mini-flared, phacoemulsification, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-flaredDevice
Mini-flared Kelman tip
Reversed tipDevice
Reversed Kelman tip
| Study group | Role | What they receive |
|---|---|---|
| Reversed tip | Active comparator | Reversed Kelman tip Receives: Device: Mini-flared |
| Mini-flared | Experimental | Mini-flared Kelman tip Receives: Device: Reversed tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities
Measured: 90 days
Secondary outcomes (1)
Phaco time used
Measured: 1 day, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Oftalmologico de Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PATRICK FRENSEL DE MORAES TZELIKIS, Hospital Oftalmologico de Brasilia
- Investigators
- Patrick F Tzelikis, MD, PhD, Principal investigator, Hospital Oftalmologico de Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089698
- Sponsor's protocol ID
- 2014.03
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vargas LG, Holzer MP, Solomon KD, Sandoval HP, Auffarth GU, Apple DJ. Endothelial cell integrity after phacoemulsification with 2 different handpieces. J Cataract Refract Surg. 2004 Feb;30(2):478-82. doi: 10.1016/S0886-3350(03)00620-5.
PubMed 15030845Payne M, Georgescu D, Waite AN, Olson RJ. Phacoemulsification tip vacuum pressure: Comparison of 4 devices. J Cataract Refract Surg. 2006 Aug;32(8):1374-7. doi: 10.1016/j.jcrs.2006.02.066.
PubMed 16863978Frohn A, Dick HB, Fritzen CP. Corneal impact of ultrasound and bevel position in phacoemulsification. J Cataract Refract Surg. 2002 Sep;28(9):1667-70. doi: 10.1016/s0886-3350(02)01306-8.
PubMed 12231329
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-flared Kelman Tip and Reverse Tip With Torsional Phaco: Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT02089698
- Acronym / sponsor ID
- 2014.03
- Conditions
- Cataract
- Keywords
- Kelman tip, Mini-flared, phacoemulsification, cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Oftalmologico de BrasiliaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.
Detailed description
In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).
The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reversed tip | Active comparator | Device: Mini-flaredReversed Kelman tip |
| Mini-flared | Experimental | Device: Reversed tipMini-flared Kelman tip |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.
Key exclusion criteria (1 listed)
- Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-flaredMini-flared Kelman tip | Device | Reversed tip |
| Reversed tipReversed Kelman tip | Device | Mini-flared |
Primary outcome
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities
Time frame: 90 days
1 secondary outcome
Phaco time used
Time frame: 1 day, 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Results publication: PubMed 15030845Vargas LG, Holzer MP, Solomon KD, Sandoval HP, Auffarth GU, Apple DJ. Endothelial cell integrity after phacoemulsification with 2 different handpieces. J Cataract Refract Surg. 2004 Feb;30(2):478-82. doi: 10.1016/S0886-3350(03)00620-5.
- Results publication: PubMed 16863978Payne M, Georgescu D, Waite AN, Olson RJ. Phacoemulsification tip vacuum pressure: Comparison of 4 devices. J Cataract Refract Surg. 2006 Aug;32(8):1374-7. doi: 10.1016/j.jcrs.2006.02.066.
- Results publication: PubMed 12231329Frohn A, Dick HB, Fritzen CP. Corneal impact of ultrasound and bevel position in phacoemulsification. J Cataract Refract Surg. 2002 Sep;28(9):1667-70. doi: 10.1016/s0886-3350(02)01306-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick F Tzelikis, MD, PhD principal investigator
Hospital Oftalmologico de Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mini-flared and Reversed tip in people with Cataract, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Treatment Diabetic Retinopathy (ETDRS) visual acuities (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089698, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.